Fish Oil-derived Omega-3 Fatty Acids on Gut Microbiota and Lipid Metabolome in Type 2 Diabetes Mellitus: a Randomized, Double-blind, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Concentration of high-density lipoprotein cholesterol
研究概览
简要总结
The objective of this research was to investigate the impact of Omega-3 PUFAs on the gut microbiota and serum lipid metabolites in participants diagnosed with type 2 diabetes, employing high-throughput sequencing technology and untargeted lipidomics.
详细描述
The pathogenesis of diabetes is associated with perturbations in lipid metabolism and intestinal flora. Nevertheless, the precise impact of Omega-3 polyunsaturated fatty acids (Omega-3 PUFAs) on key lipid metabolites, intestinal microorganisms, and fungi linked to type 2 diabetes remains indeterminate. The objective of this research was to investigate the impact of Omega-3 PUFAs on the gut microbiota and serum lipid metabolites in participants diagnosed with type 2 diabetes, employing high-throughput sequencing technology and untargeted lipidomics. The investigators randomly allocated 110 eligible participants into either the fish oil intervention group or the placebo control group for a 3-month double-blind randomized intervention trial. Bacterial 16S rDNA, fungal diversity analysis of Internally Transcribed Spacer sequences (ITS) and untargeted lipidomics were used to investigate the effects of Omega-3 PUFAs on intestinal microbiota and serum lipid metabolites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
The study was a randomised, double-blind trial, and neither the subjects nor the research workers knew the exact subgroups or the progress of the treatment
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes have been diagnosed;
- •Male or female aged 18-70 years;
- •After listening to the project presentation, voluntarily participate in the study and sign an informed consent form.
排除标准
- •Pregnant or lactating women;
- •Poorly controlled diabetes, i.e. HbA1c>9%；
- •Have taken omega-3 PUFAs-related supplements in the past six months；
- •Taking lipid-lowering drugs or other drugs that affect blood lipid metabolism；
- •Patients with severe diabetic complications, severe hypertension, combined with
- •diseases of the heart, brain, liver, kidney, thyroid and hematopoietic system, psychosis；
- •Patients with severe immune system disorders；
- •Have special diets: vegetarians, weight managers, ketogenic test takers, etc；
- •The attending physician deems the participant unsuitable
结局指标
主要结局
Concentration of high-density lipoprotein cholesterol
时间窗: 12 weeks
physiological parameter
hip measurement
时间窗: 12 weeks
physiological parameter
Concentration of Serum triglycerides
时间窗: 12 weeks
physiological parameter
Concentration of low-density lipoprotein cholesterol
时间窗: 12 weeks
physiological parameter
height in meters
时间窗: 12 weeks
physiological parameter
Diastolic blood pressure
时间窗: 12 weeks
physiological parameter
Concentration of total cholesterol
时间窗: 12 weeks
physiological parameter
weight in kilograms
时间窗: 12 weeks
physiological parameter
body mass index (BMI)
时间窗: 12 weeks
BMI=weight(kg)/height\^2(m)
waist circumference
时间窗: 12 weeks
physiological parameter
Systolic blood pressure
时间窗: 12 weeks
physiological parameter
次要结局
- Incidence of diabetes complications(12 weeks)
- Number of Participants who take drugs(12 weeks)
- Rate of smoking among participants(12 weeks)
研究者
Jia-yue Xia
Principal Investigator
The First Affiliated Hospital with Nanjing Medical University